The present disclosure describes improvements to the electrodes employed when using and operating a small, thin coin-sized electroacupuncture (EA) device of the type described in the related applications referenced above in Paragraph [0001], or equivalent small, self-contained, stimulators adapted for implantation under the skin. More particularly, the present disclosure relates to a preferred scheme for configuring the electrodes on the housing of an implantable EA device.
In accordance with the teachings of the applications referenced above, a self-contained, coin-sized stimulator may be implanted in a patient at or near a specified target tissue location, e.g., one or more acupoint(s), in order to favorably treat a condition or disease of a patient. The coin-sized stimulator referenced in the previously-filed patent applications is referred to as an implantable electroacupunture device (IEAD). Such IEAD advantageously applies electrical stimulation pulses at very low duty cycles in accordance with a specified stimulation regimen through electrodes that either form an integral part of the housing of the stimulator, or are closely coupled thereto through a very short lead. A small, thin, coin-cell type battery inside of the IEAD case provides enough stored energy for the IEAD to carry out its specified stimulation regimen over a period of several years. Thus, the IEAD, once implanted, provides an unobtrusive, needleless, long-lasting, elegant and effective mechanism for treating certain conditions and diseases that have long been treated by acupuncture or electroacupuncture.
The ability of the IEAD to apply its low level stimulation through the electrodes that are attached to, carried by, or otherwise form a part of the housing of the IEAD is, in large part, a function of how well such electrodes are able to direct and focus the applied stimulation to the target tissue location(s) of interest, e.g., a designated acupoint(s), and to the tissue and nerves associated with such target location. The present disclosure is directed to techniques and schemes that accomplish that goal.
It is noted that traditional acupuncture and acupressure have been practiced in Eastern civilizations (principally in China, but also in other Asian countries) for at least 2500 years. It is still practiced today throughout many parts of the world, including the United States and Europe.
Acupuncture is an alternative medicine that treats patients by insertion and manipulation of needles in the body at selected points. The locations where the acupuncture needles are inserted are referred to as “acupuncture points” or simply just “acupoints”. The location of acupoints in the human body has been developed over thousands of years of acupuncture practice, and maps showing the location of acupoints in the human body are readily available in acupuncture books or online, see, e.g., WHO STANDARD ACUPUNCTURE POINT LOCATIONS IN THE WESTERN PACIFIC REGION, published by the World Health Organization (WHO), Western Pacific Region, 2008 (updated and reprinted 2009), ISBN 978 92 9061 248 7 (hereafter “WHO Standard Acupuncture Point Locations 2008”). This reference, i.e., the WHO Standard Acupuncture Point Locations 2008, is incorporated herein by reference.
In classical acupuncture treatment, once needles are inserted at a desired acupoint location(s), the needles are typically mechanically modulated for a short treatment time, e.g., 30 minutes or less. The needles are then removed until the patient's next visit to the acupuncturist, e.g., in 1-4 weeks (or longer), when the process is repeated. Over several visits, the patient's condition or disease is effectively treated, offering the patient needed relief and improved health.
In electroacupuncture (EA) treatment, needles are inserted at specified acupoints, as in classical acupuncture treatment, but the needles, once inserted, are then connected to an external source of electrical radio frequency (RF) energy, and electrical stimulation signals, at a specified frequency and intensity level, are then applied to the patient's body through the needles at the acupoint(s), thereby also providing the patient with a measure of needed and desired treatment for his or her condition or disease.
While some controversy may still exist as to the precise mechanism by which the insertion of needles into body tissue at selected acupoint(s) achieves its beneficial results, the successful activation of nerve fibers (whether through mechanical modulation or electrical modulation) at the acupoint(s) is thought by most to be a key element necessary for effective acupuncture treatment. See, e.g., “Longhurst, Defining Meridians: A Modern Basis of Understanding,” J Acupunct Meridian Stud 2010; 3(2):67-74
U.S. Pat. No. 6,735,475, issued to Whitehurst et al., discloses use of an implantable miniature neurostimulator, referred to as a “microstimulator,” that can be implanted into a desired tissue location and used as a therapy for headache and/or facial pain. The microstimulator has a tubular shape, with electrodes at each end.
Other patents of Whitehurst et al. teach the use of this small, microstimulator, placed in other body tissue locations, including within an opening extending through the skull into the brain, for the treatment of a wide variety of conditions, disorders and diseases. See, e.g., U.S. Pat. No. 6,950,707 (obesity and eating disorders); U.S. Pat. No. 7,003,352 (epilepsy by brain stimulation); U.S. Pat. No. 7,013,177 (pain by brain stimulation); U.S. Pat. No. 7,155,279 (movement disorders through stimulation of Vagus nerve with both electrical stimulation and drugs); U.S. Pat. No. 7,292,890 (Vagus nerve stimulation); U.S. Pat. No. 7,203,548 (cavernous nerve stimulation); U.S. Pat. No. 7,440,806 (diabetes by brain stimulation); U.S. Pat. No. 7,610,100 (osteoarthritis); and U.S. Pat. No. 7,657,316 (headache by stimulating motor cortex of brain).
Techniques for using electrical devices, including external EA devices, for stimulating peripheral nerves and other body locations for treatment of various maladies are known in the art. See, e.g., U.S. Pat. Nos. 4,535,784; 4,566,064; 5,195,517; 5,250,068; 5,251,637; 5,891,181; 6,393,324; 6,006,134; 7,171,266; and 7,171,266. The methods and devices disclosed in these patents, however, typically utilize (i) large implantable stimulators having long leads that must be tunneled through tissue or blood vessels over an extended distance to reach the desired stimulation site, (ii) external devices that must interface with implanted electrodes via percutaneous leads or wires passing through the skin, or (iii) inefficient and power-consuming wireless transmission schemes. Such devices and methods are far too invasive, and/or are ineffective the treatment provided.
From the above, it is seen that there is a need in the art for a less invasive device and technique for electroacupuncture stimulation of acupoints, or other target tissue locations, that does not require the continual use of needles inserted through the skin, or long insulated wires implanted or inserted into blood vessels, for the purpose of treating an illness or deficiency of a patient.
Moreover, as will be seen from the description that follows, the electrodes used with any implantable electroacupuncture device must be optimally configured so that the applied stimulation current achieves its intended purpose of acting and interacting with nerve fibers and tissue so as to produce desired efficacious results. The innovations described herein address that need.